510(k) · Cleared
ClearedSalvin Dental Specialties, Inc., Fixation Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salvin Dental Specialties, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Mar 26, 2008 as substantially equivalent to K023260 (Osteomed Corp., 2002) and 3 other predicates after a 119-day review. Its family tree reaches back 5 generations to 1976. 5 later devices descend from it.
- Decided
- Mar 26, 2008
- Review
- 119 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K761228 (1976). 18 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 4 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 3 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 2 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 1 generation backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- This deviceK073342 Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 3 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK103084 Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S · 2011
Most influential descendants
Showing 5 of 5 · See all- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · cites it directly3descendants
- K170697GBR systemSurgident · 2018 · 2 generations on2descendants
- K222367Save GBRDentis Co., Ltd. · 2023 · 3 generations on0descendants
- K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020 · 3 generations on0descendants
- K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −4 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −1 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| 0 (this device) | K073342 | Salvin Dental Specialties, Inc., Fixation Screw | Salvin Dental Specialties, Inc. | 2008 | — |
| +1 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +2 | K170697 | GBR system | Surgident | 2018 | — |
| +3 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +3 | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020 | — |
| +1 | K103084 | Neodent Graft Screw | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023260 | 1.2MM Osteomed Auto-Drive Screw SystemSummary page 1…Fixation Screw Classification Name Screw, Fixation, Bone (21 CFR 888.3040, Product code HWC) C Predicate Device(s) K023260 - Osteomed Auto-Drive Screw System K970912 - Leibinger Self-Drilling Screw… | 2002 |
| * | K970912 | Leibinger Self-Drilling ScrewSummary page 1…(21 CFR 888.3040, Product code HWC) C Predicate Device(s) K023260 - Osteomed Auto-Drive Screw System K970912 - Leibinger Self-Drilling Screw K050492 -Integra Bone Fixation System… | 1997 |
| * | K050492 | Integra Bone Fixation SystemSummary page 1…Predicate Device(s) K023260 - Osteomed Auto-Drive Screw System K970912 - Leibinger Self-Drilling Screw K050492 -Integra Bone Fixation System K040860 - Integra Bone Fixation System D Device Description… | 2005 |
| * | K040860 | Integra Bone Fixation SystemSummary page 1…m K970912 - Leibinger Self-Drilling Screw K050492 -Integra Bone Fixation System K040860 - Integra Bone Fixation System D Device Description The Salvin Dental Specialties Titanium Fixation Screw… | 2004 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K141764 (Impladent, Ltd., 2014) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K023260.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction.
Single patient use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073342 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073342: Salvin Dental Specialties, Inc., Fixation Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073342
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026